| CTRI Number |
CTRI/2025/09/094958 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
to see action of durvadi ghrita and saptavinshati guggulu in non healing ulcer |
|
Scientific Title of Study
|
Clinical evaluation of Durvadi Ghrita local application along with Saptavinshati Guggulu orally in Dushta Vrana |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saumya Nawani |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 15 Department of Shalya-Tantra Patanjali ayurved
hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan
Delhi haridwar highway 58 Haridwar Uttarakhand India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9627716036 |
| Fax |
|
| Email |
saumya.nawani02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saurabh Sharma |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 15 Department of Shalya-Tantra Patanjali ayurved
hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan
Delhi haridwar highway 58 Haridwar Uttarakhand India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7020108714 |
| Fax |
|
| Email |
surgeonsaurabh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saurabh Sharma |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 15 Department of Shalya-Tantra Patanjali ayurved
hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan
Delhi haridwar highway 58 Haridwar Uttarakhand India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7020108714 |
| Fax |
|
| Email |
surgeonsaurabh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Yogpeeth Phase1, Roorkee road,
Haridwar, Uttarakhand, India 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,
Haridwar, Uttarakhand, India 249405 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saumya Nawani |
Patanjali Bhartiya Ayurvigyan Evam Sansthan Haridwar |
Opd 15, Department of
Shalya Tantra ,
Hardwar
UTTARANCHAL |
09627716036
saumya.nawani02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN,HARIDWAR UTTARAKHAND |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Durvadi Ghrita , Reference: Chakradatta Chapter-44 Shloka-92, Route: Topical, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Saptavinshati Guggulu, Reference: Yogaratnakar Uttarardha Bhagandar Chikitsa Chapter-, Route: Oral, Dosage Form: Guggulu , Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Luke warm Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient at age group between 18 to 70 years
Patient willing to undergo trial and ready to give informed and written consent
Patient irrespective of sex religion socioeconomic status and occupation will be taken
Patient with the clinical features of Dushta Vrana
Diabetes ulcers DM under control
Varicose ulcers
|
|
| ExclusionCriteria |
| Details |
Patient of all genders age less than 18 years and more than 70 years
Patient not willing to undergo trial and not ready to give informed and written consent
Patients with evidence of malignancy and malignant ulcer
Syphilitic ulcer
Soft chancre sores ducreys
Diabetes mellitus uncontrolled
Patients suffering from chronic renal disease
Tubercular ulcers
Hepatitis B Hepatitis C HIV
•Syphilitic ulcers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective Parameters: -
1.Pain (Vedana)
2.Discharge (Strava)
3.Itching (Kandu)
4.Oedema (Shotha)
5.Odour (Gandha)
|
assessment will be done at baseline followed by weekly assessment for 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective Parameters: -
1.Pain (Vedana)
2.Discharge (Strava)
3.Itching (Kandu)
4.Oedema (Shotha)
5.Odour (Gandha)
|
follow up to 3 months |
Subjective Parameters: -
1.Pain (Vedana)
2.Discharge (Strava)
3.Itching (Kandu)
4.Oedema (Shotha)
5.Odour (Gandha)
|
follow up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this trial we are selecting patient of Dushta Vrana and taking single group of patient. We will do interventional with standard Durvdi Ghrita and Saptavinshati Guggulu. Intervention study will be done on the basis of assessment based on Subjective and Objective parameters. Subjective parameters include,pain,discharge , itching, edema and odour and objective parameters includes size of ulcer , granulation tissue floor. Result will be analyzed statistically and discussed accordingly. |